Unifer

Contraindications

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What is the most important information I should know about Unifer?

Disturbances in iron utilization (lead anemia), Thalassemia.

Hypersensitivity or intolerance to iron and overloading of iron in the body.

Anemia not caused by iron deficiency.

Undesirable effects

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What are the possible side effects of Unifer?

Applies to Unifer: capsules, tablets

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; darkened or green stools; diarrhea; loss of appetite; nausea; stomach cramps, pain, or upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur while taking Unifer (the active ingredient contained in Unifer)

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; severe or persistent nausea, stomach pain, or vomiting; vomit that looks like blood or coffee grounds.

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Oral

Iron-deficiency anaemia

Adult: Expressed in terms of elemental iron. Treatment: 60 mg bid up to 60 mg 4 times daily. Prevention: 60 mg daily.

Child: Expressed in terms of elemental iron. Treatment: Severe: 4-6 mg/kg/day in 3 divided doses; Mild to moderate: 3 mg/kg/day in 1-2 divided doses. Prevention: 1-2 mgkg/day.

Unifer is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Unifer is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body).

Unifer may also be used for purposes not listed in this medication guide.

Name of the medicinal product

Unifer

Qualitative and quantitative composition

A metallic element found in certain minerals, in nearly all soils, and in mineral waters. It is an essential constituent of hemoglobin, cytochrome, and other components of respiratory enzyme systems. Its chief functions are in the transport of oxygen to tissue (hemoglobin) and in cellular oxidation mechanisms. Depletion of iron stores may result in iron-deficiency anemia. Unifer is used to build up the blood in anemia.

Special warnings and precautions for use

Use Unifer as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Unifer is absorbed better on an empty stomach but may be taken with food if it upsets your stomach. Some foods (eg, eggs, whole grain breads, cereal, dairy products, coffee, tea) may decrease the amount of iron absorbed by your body. Talk with your doctor about the best way to take Unifer with food if it upsets your stomach.
• If you take an antacid, a bisphosphonate (eg, alendronate), cefdinir, eltrombopag, methyldopa, penicillamine, a quinolone antibiotic (eg, ciprofloxacin), or a tetracycline antibiotic (eg, minocycline), ask your doctor or pharmacist how to take it with Unifer.
• Take Unifer with a full glass of water (8 oz [240 mL]). Do not lie down for 30 minutes after taking Unifer.
• Unifer must be swallowed whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Unifer, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Unifer.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications

Iron-deficiency anemia: Prevention and treatment of iron-deficiency anemias

Dosage (Posology) and method of administration

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral:

Generic: 240 mg [elemental iron 27 mg], 324 mg [elemental iron 38 mg]

Tablet,

Oral [preservative free]:

Unifer: 240 mg [elemental iron 27 mg] [corn free, dairy free, egg free, fragrance free, gluten free, no artificial flavor(s), sodium free, soy free, starch free, sugar free, wheat free, yeast free; contains fd&c blue #1 aluminum lake, fd&c yellow #6 aluminum lake]

Generic: 324 mg [elemental iron 37.5 mg]

Dosing: Adult

Note: Immediate release oral iron products are preferred for treatment of iron deficiency anemia; enteric coated and slow/sustained release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012). Dose expressed in terms of elemental iron; Unifer contains ~12% elemental iron.

Iron-deficiency anemia, prevention in areas where anemia prevalence is ≥40% (off-label use):

Oral: Menstruating women (nonpregnant females of reproductive potential): 30 to 60 mg elemental iron/day for 3 consecutive months in a year (WHO 2016a).

Iron-deficiency anemia, treatment:

Oral: 65 to 200 mg elemental iron/day (Liu 2012; Schrier 2019; Stoltzfus 1998; WHO 2001); may administer in up to 3 divided doses. Note: Alternate-day dosing (eg, every other day or Monday, Wednesday, Friday) has been shown to result in greater absorption of iron; some experts recommend this dosing schedule in patients who can maintain adherence (Schrier 2019; Stoffel 2017).

Dosing: Geriatric

Lower doses (15 to 50 mg elemental iron/day) may have similar efficacy and less GI adverse events (eg, nausea, constipation) as compared to higher doses (eg, 150 mg elemental iron/day) (Rimon 2005).

Dosing: Pediatric

Note: Doses expressed as elemental iron. Unifer contains ~12% elemental iron.

Iron deficiency, prevention in areas where anemia prevalence is >40%:

Oral:

Infants ≥6 months and Children <2 years: 10 to 12.5 mg daily for 3 consecutive months in a year (WHO 2016b)

Children 2 years to <5 years: 30 mg daily for 3 consecutive months in a year (WHO 2016b)

Children ≥5 to 12 years: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016b)

Adolescent menstruating females (non-pregnant females of reproductive potential): 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016a)

Iron deficiency, treatment:

Oral: Children and Adolescents: 3 to 6 mg/kg/day in 3 divided doses; suggested maximum daily dose: 200 mg/day (ASPEN Pediatric Nutrition Support Core Curriculum [Corkins 2015]; Kliegman 2016)

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Unifer?

Metformin In healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean cmax and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug.

Although not observed in this study, adverse effects could potentially arise from co-administration of cephalexin and metformin by inhibition of tubular secretion via organic cationic transporter systems. Accordingly, careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin.

Probenecid As with other b-lactams, the renal excretion of cephalexin is inhibited by probenecid.

Drug / Laboratory Test Interactions

As a result of administration of Keflex, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedictís and Fehlingís solutions and also with Clinitest® tablets.